510(k) K971660 ยท FDS Gastroscope And Accessories, Flexible/Rigid
OLYMPUS GF-UM130 ULTRASOUND GASTROVIDEOSCOPE, ITS ASSOCIATED ACCESSORIES AND ANCILLARY EQUIPMENT
| Applicant | Olympus America, Inc., Melville NY, US |
| Decision | Substantially Equivalent, Jul 25, 1997 |
| Received | May 6, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971660
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 16, 2020 | Olympus Corporation of the Americas Olympus Ultrasound Endoscope, Model number: GF-UM130 - Product Usage: used with an Olympus Endoscopic Ultrasound Center, EVIS Video System Center, light source, documentation equipment, video monitor, Terminated |
FDS | None listed |
| Oct 16, 2020 | Olympus Corporation of the Americas Olympus Ultrasound Endoscope, Model number: GF-UMQ130 - Product Usage: used with an Olympus Endoscopic Ultrasound Center, EVIS Video System Center, light source, documentation equipment, video monitor Terminated |
FDS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.